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Clinico-biological Data Collection Study of Metastatic Breast Cancer (EPICUREseinmet)

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ClinicalTrials.gov Identifier: NCT03958136
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborators:
European Regional Development Fund
AstraZeneca
Novartis
Eli Lilly and Company
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Tracking Information
First Submitted Date  ICMJE December 31, 2018
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date May 24, 2019
Actual Study Start Date  ICMJE December 24, 2018
Estimated Primary Completion Date December 24, 2033   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Creation of complex prospective clinico-biological database in metastatic breast cancer [ Time Frame: At each progressive disease, 15 years after inclusion ]
    specific metastatic biopsy intervention
  • Creation of complex prospective clinico-biological database in metastatic breast cancer [ Time Frame: At each progressive disease, 15 years after inclusion ]
    search of algorithms combining multiple data (clinical, biological, imaging) in breast cancer management
  • Overall survival [ Time Frame: 15 years after inclusion ]
    Overall Survival is the delay between the date of inclusion and the date of death or last follow-up assessment if censored.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03958136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Progression free survival [ Time Frame: 15 years after inclusion ]
    Progression Free survival is the delay between the first dose of a treatment sequence and the date of documented disease progression or death
  • Quality of life during treatment [ Time Frame: every 4-6 months for 15 years after inclusion ]
    QLQ-C30 Questionnaire (total score)
  • Quality of life during treatment [ Time Frame: every 4-6 months for 15 years after inclusion ]
    BR23 Questionnaire (total score)
  • Quality of life during treatment [ Time Frame: every 4-6 months for 15 years after inclusion ]
    STAI anxiety Questionnaire (total score)
  • Quality of life during treatment [ Time Frame: every 4-6 months for 15 years after inclusion ]
    Beck Depression Inventory (BDI) (total score)
  • Response to treatment for each therapeutic sequence [ Time Frame: every 4-6 months for 15 years after inclusion ]
    RECIST 1.1 or iRECIST assessment
  • Response to treatment for each therapeutic sequence [ Time Frame: every 4-6 months for 15 years after inclusion ]
    biological assessment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinico-biological Data Collection Study of Metastatic Breast Cancer
Official Title  ICMJE Prediction in Silico of Overall Survival in a Pilot Prospective Cohort Study of Metastatic Breast Cancer Patients
Brief Summary

RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.

PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and bio-pathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

Detailed Description

This prospective study will be conducted on first line metastatic breast cancer patients.

Three phenotypic groups are identified on immunohistochemistry done at inclusion: on metastatic sites or breast tumor if local recurrence, usual treatment protocols are often guided by the following groups:

  • Group 1 : Patients HR (Hormon Receptor) + (E (Estrogen Receptor) + and/or PR (Progesterone Receptor) +) and HER2- (Human Epidermal Growth Factor Receptor-2)
  • Group 2 : Patients HER2 + with or without HR+
  • Group 3 : Patients triple negative (HR- and HER2-) Patients will receive treatments as per standard care according to the patient group.

Standard treatments recommended for treatment first line are:

  1. For group 1 : For HR + and HER2- patients :

    • For patients requiring Chemotherapy (visceral crisis), the recommended treatment is : Taxanes based chemotherapy Anthracyclines based chemotherapy
    • For the patients without visceral crisis: the recommended treatment is : Hormonal therapy combined with CDK 4-6 inhibitors (Cyclin-dependent kinase) as recommended in standard care.
  2. For group 2 : HER2 + (with or without HR+), the recommended treatment is :

    • Paclitaxel (Taxol) combined with Trastuzumab (Herceptin) and Pertuzumab (Perjeta) as per the institutional standard of care.
    • Docetaxel (Taxotere) combined with Trastuzumab (Herceptin) and Pertuzumab (Perjeta) as per the institutional standard of care.
  3. For group 3 : triple negative (HR- and HER2-) patients, the recommended treatment is :

    • Paclitaxel (Taxol) with or without Bevacizumab (Avastin) as per the institutional standard of care.

Further treatment lines are administered according to standard practice. Biological and histological assessments are performed on specific metastasis biopsy samples done at baseline and at each progression.

Physical exam, standard laboratory tests, imaging (CT (computerized tomography) scan, PET-CT (Positron emission tomography-computed tomography) and bone scan (for patients with bone metastasis) will be performed every 2 to 6 months according to patient group.

Clinical, biological, pathological, epidemiological, socio-economic and multi-omic data will be collected throughout the study duration.

These massive data will be used to create new algorithms in order to help clinicians to predict treatment response.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
monocentric, open, prospective database with specific biopsy and blod collections done (biocollection)
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Procedure: Metastasis biopsy
    Metastasis biopsy will be performed for multi-omic analysis
  • Biological: Biomarkers blood, urine and microbiota samples
    Biomarkers blood, urine and microbiota samples for multi-omic analysis
  • Behavioral: Patient Reported Outcome (PRO)
    Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.
Study Arms  ICMJE
  • Experimental: Patients HR + and HER2-

    At each disease progression, patient will have specific interventions :

    • Metastasis biopsy
    • Biomarkers blood, urine and microbiota samples
    • Patient Reported Outcome (PRO)
    Interventions:
    • Procedure: Metastasis biopsy
    • Biological: Biomarkers blood, urine and microbiota samples
    • Behavioral: Patient Reported Outcome (PRO)
  • Experimental: Patients HER2 + with or without HR+

    At each disease progression, patient will have specific interventions :

    • Metastasis biopsy
    • Biomarkers blood, urine and microbiota samples
    • Patient Reported Outcome (PRO)
    Interventions:
    • Procedure: Metastasis biopsy
    • Biological: Biomarkers blood, urine and microbiota samples
    • Behavioral: Patient Reported Outcome (PRO)
  • Experimental: Patients triple negative (HR- and HER2-)

    At each disease progression, patient will have specific interventions :

    • Metastasis biopsy
    • Biomarkers blood, urine and microbiota samples
    • Patient Reported Outcome (PRO)
    Interventions:
    • Procedure: Metastasis biopsy
    • Biological: Biomarkers blood, urine and microbiota samples
    • Behavioral: Patient Reported Outcome (PRO)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2034
Estimated Primary Completion Date December 24, 2033   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample, faeces and questionnaires
  2. Women > 18 years old at time of written consent
  3. Patient with histologically confirmed breast cancer
  4. Breast cancer metastatic disease or locally advanced not eligible for local curative treatment intent with or without personal history of adjuvant therapy for this cancer (chemotherapy, radiotherapy, surgery …)
  5. Patient with metastases that can be biopsied.
  6. Performance status ≤ 2 (according to WHO criteria)
  7. Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations.
  8. HR and HER2 status on metastatic sites or breast tumor if local recurrence:

    • For group 1 :

      • Histologic and/or cytological confirmation of estrogen-receptor positive (ER+) and/ or progesterone receptor positive (PR+) breast cancer determined by local laboratory testing
      • No HER2-overexpression in the patient's tumor tissue determined by local laboratory testing
    • For group 2 :

      • Histologic and/or cytological confirmation of estrogen-receptor positive or negative and/ or progesterone receptor positive or negative breast cancer determined by local laboratory testing
      • HER2-overexpression in the patient's tumor tissue determined by local laboratory testing
    • For group 3 :

      • Histologic and/or cytological confirmation of estrogen-receptor negative and progesterone receptor negative breast cancer determined by local laboratory testing
      • No HER2-overexpression in the patient's tumor tissue determined by local laboratory testing
  9. Menopausal status : as per the institutional standard of care
  10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  11. Patient must be affiliated to a Social Health Insurance

Exclusion Criteria:

  1. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)
  2. Coagulopathy or other pathology that contraindicates biopsy procedures
  3. Prior systemic treatment in metastatic setting
  4. Patients with exclusive brain metastasis not available for surgery
  5. Pregnant or nursing patient
  6. Individual deprived of liberty or placed under the authority of a tutor
  7. Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mario CAMPONE, MD, PhD +33240679900 ext 9510 mario.campone@ico.unicancer.fr
Contact: Marine TIGREAT +33240679900 ext 9878 marine.tigreat@ico.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958136
Other Study ID Numbers  ICMJE ICO-N-2017-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Cancerologie de l'Ouest
Study Sponsor  ICMJE Institut Cancerologie de l'Ouest
Collaborators  ICMJE
  • European Regional Development Fund
  • AstraZeneca
  • Novartis
  • Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Mario CAMPONE, MD, PhD Institut de Cancerologie de l'Ouest
PRS Account Institut Cancerologie de l'Ouest
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP